CTRI/2022/04/042014进行中（未招募）2 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Trial to Evaluate the Efficacy and Safety of ASLAN004 in Patients with Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 295
- 试验地点
- 7
- 主要终点
- Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16
研究概览
简要总结
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel, dose-ranging clinical study designed to evaluate the efficacy and safety of ASLAN004 in adolescent and adult patients with moderate-to-severe AD who are candidates for systemic therapy.
The study consists of a 16-week treatment period, 8-week follow-up period up to Week 24, followed by a telephone safety follow-up call at Week 28. The primary efficacy endpoint will be assessed at Week 16. A Screening period of not greater than 35 days and the reconfirmation of key eligibility criteria at Day 1 are pre-requisites for the randomization of patients.
Approximately 295 patients meeting the eligibility criteria will be randomized automatically and randomly through RTSM (Randomization Trial Supply Management) and will be allocated into one of the 5 treatment arms (4 active treatment arms and 1 placebo arm) in a 1:1:1:1:1 equal ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients, who are 12 years or older and weighing at least 40 kg (at this time of consent), and provide written informed consent and authorization for release and use of protected health information.
- •Patients who meet the legal age for study participation in their respective country, and are able to read and understand, and willing to sign the informed consent form are considered adults.
- •Refer to Section 7.3.11;
- •Willing and able to comply with clinic visits and study-related procedures
- •Have a clinical diagnosis of chronic AD as per Eichenfield revised criteria of Hanifin and Rajka (Appedix 1, that has been present for at least 1 year prior to the Screening visit
- •Have an vIGA score of greater than or equal to 3 (5 point scale, 0-4) at the Screening and Baseline visits;
- •Have greater than or equal to 10% BSA of AD involvement at the Screening and Baseline visits;
- •Have an EASI score ≥16 at the Screening and Baseline visits;
- •Have a history of inadequate response to, intolerance to or contraindication to a stable (≥1 month) regimen of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) as treatment for AD
- •HHave applied, twice daily, a consistent amount of a topical emollient (moisturizer) as approved by the investigator, for at least 7 days prior to randomization;.
排除标准
- •1.Immunosuppressive/immunomodulating drugs, systemic therapies or phototherapy within 4 weeks prior to randomization.
- •2.Have had treatment with leukotriene inhibitors within 4 weeks prior to randomization unless in the opinion of the investigator will not impact the study assessments 3.Treatment with topical therapies (including TCS, TCI, topical phosphodiesterase inhibitors, topical JAK inhibitors) or prescription moisturizers, within 1 week prior to randomization 4.Previous treatment at any time prior to randomization with monoclonal antibody / biologic therapeutic agents as follows: a.
- •Prior exposure to dupilumab (Dupixent®) which was discontinued due to lack of efficacy, loss of response, or adverse event.
- •b.Investigational or approved agents targeting interleukins IL-4 or IL-13 ligands or receptors of IL-4 or IL-13, including but not limited to lebrikizumab, tralokinumab or ASLAN004 c.Other investigational or approved biologic drug within 16 weeks or within 5 half-lives (if known), whichever is longer, prior to the Baseline visit.
- •d.Cell-depleting biologics, including, but not limited to, rituximab within 6 months prior to the Baseline visit.
- •5.Inadequate organ function, abnormal lab result, uncontrolled blood pressure or other health condition considered clinically significant by the investigator at the Screening visit.
- •6.History of HIV, Hepatitis B, Hepatitis C or active/latent Tuberculosis infection; 7.History of immunosuppression including history of invasive opportunistic infections; 8.Treatment with live attenuated vaccine within 8 weeks prior to randomization; 9.Parasitic infection within 4 weeks prior to randomization travel within 3 months prior to randomization to areas of high parasitic exposure; 10.Have skin comorbidities that in the opinion of the Investigator may interfere with study assessments; 11.Female individuals who do not comply with the following contraception requirements: A female individual is not eligible to participate if she is pregnant or breastfeeding, or is a woman of childbearing potential (WOCBP) at risk for pregnancy who is not using two forms of effective birth control during the intervention period and for at least 12 weeks after the last dose of study medication as outlined in Appendix
- •The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
- •Women in the following categories are not considered WOCBP: a.
- •Premenarchal.
- •Premenopausal female with 1 of the following: • Documented hysterectomy; • Documented bilateral salpingectomy; • Documented bilateral oophorectomy.
- •For individuals with permanent infertility due to an alternate medical cause other than the above, (eg, Müllerian agenesis, androgen insensitivity), Investigator discretion should be applied to determine study entry.
- •Note: Documentation for any of the above categories can come from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview.
- •The method of documentation should be recorded in the participant’s medical record for the study.
- •Postmenopausal female: • A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- •The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •Documentation of this review should be included in the participant’s medical record for the study.
- •Females of childbearing potential must have negative serum pregnancy test at the Screening visit and negative urine pregnancy test at Day 1 12.Patients unwilling to use adequate birth control.
结局指标
主要结局
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16
时间窗: Baseline, Week 16
次要结局
- Change in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm from Baseline to Week 16(Baseline, Week 16)
- Proportion of patients with EASI 50, 75 and 90 at Week 16(Week 16)
- Proportion of patients achieving validated Investigators Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16(Week 16)
- Proportion of patients with EASI less than 7 at Week 16(Week 16)
- Percent Change in EASI score from Baseline over time(Baseline, Week 16)
- Absolute and percent change in Pruritus Numerical Rating Scale (P-NRS) over time(Baseline, Week 16)
- Proportion of patients achieving a 4-point reduction in P-NRS(Baseline, Week 16)
- Change in Body Surface Area (BSA) affected with AD(Baseline, Week 16)
- Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16(Baseline, Week 16)
- Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration (Day 1) to Week 28(Baseline to Week 28)
- Change in Hospital Anxiety Depression Scale (HADS) from Baseline to Week 16(Baseline to Week 16)
- Change in Dermatology Life Quality Index (DLQI) from Baseline to Week 16(Baseline, Week 16)
- Change in Patient-Oriented Eczema Measure (POEM) from Baseline to Week 16(Baseline to Week 16)
- Absolute and percent change in sleep disturbance SD-NRS over time(Baseline to Week 16)
- Proportion of patients achieving a 4-point reduction in SD-NRS from Baseline to at Week 16(Baseline to Week 16)
研究者
研究点 (7)
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